Devices and methods for treating morbid obesity

ABSTRACT

A surgical method of treating morbid obesity via bariatric procedures, carried out endoluminally and transluminally using endoscopic devices that are introduced through natural body openings without the necessity of creating any incisions in the abdominal wall.

CROSS-REFERENCES TO RELATED APPLICATION

This application claims priority as a divisional application of U.S.patent application Ser. No. 11/825,694, filed on Jul. 9, 2007 now U.S.Pat. No. 7,841,503; which claims priority to Israeli patent applicationserial number 176889, filed on Jul. 16, 2006.

FIELD OF THE INVENTION

The invention is related to the field of medical devices. Morespecifically the invention relates to endoscopic devices for treatingmorbid obesity and for methods of using these devices.

BACKGROUND OF THE INVENTION

There are several methods for assessing and describing the presence ofexcess weight. However, most authorities now define excess weight interms of the Body Mass Index (BMI). The BMI is calculated by dividingthe weight in kilograms by the square of the height in meters. Forexample, a 1.75 m tall man who weighs 85 kg has a BMI of 85/(1.75)² or85/3.0625=28. A person with a height of 1.6 m having the same weightwill have a BMI of 33. Individuals are considered to suffer from morbidobesity if their BMI is ≧40.0 or if their BMI has a value of 35.0-39.9and they suffer from obesity related medical problems.

In earlier times, being obese was considered a sign of good health.However, it is now clear that obesity is associated with a number ofserious conditions, and that it is a major health risk, whose prevalenceis rising. Overweight and obesity are known risk factors for: diabetes,heart disease, stroke, hypertension, gallbladder disease,osteoarthritis, sleep apnea and other breathing problems, and some formsof cancer (uterine, breast, colorectal, kidney, and gallbladder). Inaddition obesity is associated with: high blood cholesterol,complications of pregnancy, menstrual irregularities, hirsutism, stressurinary incontinence, psychological disorders such as depression, andincreased surgical risk.

It is evident then that obesity is a major health problem and is nowconsidered an epidemic in the western world and is beginning to be aserious problem in areas of the world where it has traditionally beenvirtually unknown. The prevalence of obesity in many western countriesis alarmingly high. For example, from data available for 1999, over tenmillion people suffered from morbid obesity, as defined above, in theUnited States of America and the deaths of an estimated 300,000 to600,000 people could be related to obesity.

Despite these facts, many people regard obesity as being due to lack ofwill power and that it is solely due to bad eating habits and lack ofexercise. The consensus amongst health care professionals today howeveris that obesity is a disease in its own right. As summarized by theNational Institutes of Health in 1985 [Health Implications of Obesity.NIH Consensus Statement Online 1985 Feb. 11-13; 5(9):1-7];

Formerly, obesity was considered fully explained by the single adversebehavior of inappropriate eating in the setting of attractive foods. Thestudy of animal models of obesity, biochemical alterations in man andexperimental animals, and the complex interactions of psychosocial andcultural factors that create susceptibility to human obesity indicatethat this disease in man is complex and deeply rooted in biologicsystems. Thus, it is almost certain that obesity has multiple causes andthat there are different types of obesity.

Physical inactivity and nutrition are only two of many causal factors ofobesity, as the disease is currently understood. Other factors aregenetic predisposition, environmental factors (social and cultural),physiologic and metabolic factors, behavioral, and psychologicalconditions. There is no question that physical activity and nutritionare factors in the development, management and prevention of obesity.However, research is progressively increasing our understanding of thecritical roles played by genetic factors and psychological factors. “Thebelief that obesity is largely the result of a lack of willpower, thoughwidely held, is unsatisfactory. Studies of twins, analyses of familialaggregation, adoption studies and animal models of obesity all indicatethat obesity is the result of a high percentage of genetic as well as ofenvironmental factors.” [Friedman J M, Leptin and the Regulation of BodyWeight in Mammals. Nature, 1998; 395:763-770].

To summarize present day thinking, obesity is a disease in its ownright, and that treatment strategies should (and are) be developed tocombat it.

Current treatment options for obesity include both non-surgical andsurgical methods. Non-surgical approaches to treatment of clinicallysevere obesity include various combinations of low- or very low-caloriediets, behavioral modification, exercise, and pharmacologic agents.

The obvious solution to obesity is to eat less. It is quite obvious thatless food intake will result is weight loss. However, diet in many formshas proven inadequate to control obesity particularly in morbid obesity.Significant weight reduction, for example 20 kg over 12 weeks, can beexpected. However, in the absence of successful behavior modification,most patients regain their lost weight within 1 year. Additionally,medical complications of rapid weight loss may occur. These are usuallytreatable if recognized and their occurrence can be limited by propermedical supervision. Behavioral modification is a therapeutic approachbased on the assumption that habitual eating and physical activitybehaviors must be relearned to promote long-term weight change.Behavioral treatment also can be combined with a lesser degree ofcaloric restriction, although evidence of long-term efficacy of thismore conservative approach in persons with clinically severe obesity islacking. Increased physical activity is recommended as a component ofweight-loss programs; however, the role of exercise in promoting andsustaining weight loss has never been established. Experience with drugtherapy for clinically severe obesity has been disappointing. Althoughpharmacologic studies with anorexigenic drugs suggest short-termbenefit, prolonged and sustained weight loss has not been proved withthese agents. The general weight of the evidence that has been obtainedin recognized clinical trials is that only in rare cases of a highlydisciplined and motivated patient has safe long term weight loss beenachieved by non-surgical methods of treatment of morbid obesity.

Various surgical approaches to morbid obesity have been tried over theyears. In general, the surgical techniques can be regarded as eithermalabsorptive or restrictive.

Malabsorptive procedures modify the gastrointestinal tract so that onlya small fraction of the food intake is actually digested. Following amalabsorptive procedure, the patient can continue to gorge himself, butthe food is not fully digested, and the amount of calories and nutrientsabsorbed is small.

Restrictive procedures work by limiting food intake. Following arestrictive procedure, the patient's ability to eat is severelyrestricted. The patient can only eat a limited amount of food. Anyattempt to eat more, will result in varying degrees of discomfort. Inaddition to forcing the patient to eat less, the discomfort conditionsthe patient to chew his food well, and obtain healthier eating habits,which may outlive the restriction in certain cases.

It is possible to combine restrictive and malabsorptive procedures, andachieve greater weight loss. The leading bariatric procedure in the USright now is Roux en Y Gastric Bypass which combines stomach restrictionwith malabsorption, which is achieved by bypassing the proximal smallintestine.

In general, malabsorptive procedures are usually more technicallychallenging and result in greater weight loss. The first malabsorptiveprocedure, called the Jejuno-ileal bypass, was associated with so manylate complications that it is now abandoned. The main malabsorptiveoperations currently performed are the Scopinaro Biliopancreatic Bypassand the Duodenal Switch procedure. In competent hands these are highlysuccessful operations.

The restrictive procedures that are currently being used or have beenpracticed in the past include:

-   -   Jaw wiring is a method for restricting weight by wiring the jaws        shut. After jaw wiring, the patients can only take fluids with a        straw. This usually results in significant weight loss. However,        almost all patients regain their weight soon after the wires are        removed. In addition, a high percentage of patients cannot        tolerate the wires, and request to have them removed or remove        them by themselves [Ramsey-Stewart G, Martin. L: Jaw wiring in        the treatment of morbid obesity. Aust N Z J Surg 1985 April;        55(2):163-7].    -   Because of these limitations, jaw wiring is no longer a commonly        offered option to patients. A Medline search for Jaw wiring and        obesity showed that no articles on Jaw wiring as a treatment for        morbid obesity had been published since 1985. The last paper,        published in 1993, showed that using jaw wiring as a prelude to        bariatric operation did not influence the long-term weight loss,        when compared to controls.    -   The Intragastric balloon, sometimes known as the gastric bubble,        was introduced in the late 1980's as a non-invasive method for        treating obesity. There are a number of commercially available        balloons, usually made of silicone rubber. They are placed in        the stomach by oral endoscopy, and inflated to 400-600 ml. The        idea being that the balloon fills the stomach, restricting its        volume, and at the same time produces a sensation of satiety.        Attractive as it seemed at the time of its introduction, and in        spite of a few early clinical trials showing weight loss, a        number of randomized controlled trials failed to show its        efficacy.    -   Even in the early clinical trials, the benefit observed        disappeared quickly, even if the balloon was maintained        inflated. From these results it is evident that the intragastric        balloon is not a good solution to the problem of obesity,        although it may have a useful role in interim management of        selected patients.    -   Horizontal gastroplasty, developed by Gomez in Ohio in 1979, was        the first attempt at a gastric restrictive operation. The early        use of stapling devices in obesity surgery involved removal of        three staples from the row and firing the stapler across the top        part of the stomach. As a result, the two stomach walls are        stapled together, except at the point where the three staples        were removed, where a small gap remains. The idea being that        food, which the patient takes in, is retained in the segment of        stomach above the staple line causing the sensation of fullness.        The food then empties slowly through the gap (stoma) into the        part of the stomach below the staple line where digestion takes        place normally.    -   Early results were very encouraging. They showed that the food        in the small pouch indeed produced a sensation of satiety and        that the patients lost weight rapidly. Unfortunately, the        muscular stomach wall has a tendency to stretch and the stoma        enlarges. Sometimes the staple line failed. To combat these        problems, other procedures in which the stoma was moved to the        side and reinforced were introduced. Because the procedures        discussed below had better long-term results, horizontal        gastroplasty fell out of favor and is now practically abandoned.        However, the results of horizontal gastroplasty are still much        better than the results of non-surgical treatment, intra-gastric        balloon, or jaw wiring.    -   Vertical banded gastroplasty (VBG) was introduced by Dr. Edward        Mason, Professor of Surgery at the University of Iowa, in 1982        to overcome the shortcomings of horizontal gastroplasty        described above. Mason realized that the lesser curvature part        of the stomach had the thickest wall and was therefore least        likely to stretch; therefore he used a vertical segment of        stomach along the lesser curvature for the pouch. Additionally,        he was very meticulous in defining the size of the pouch,        measuring it at surgery under a standard hydrostatic pressure,        and has shown that best results follow the use of a very small        pouch, holding only 14 cc saline at the time of surgery. The        third modification which he made was to place a polypropylene        band (Marlex Mesh) around the lower end of the vertical pouch,        which acts as the stoma, to fix the size of the outlet of the        pouch preventing it from stretching. This is done by use of a        circular stapling instrument to staple the front and back walls        of the stomach together, cutting out a circular window to allow        the polypropylene band to be placed around the lower end of the        pouch. His extensive studies showed that the correct        circumference of the band is 5.0 cm. Correctly performed this        operation produces good weight loss results. There are few        complications associated with Vertical Banded Gastroplasty,        because all food taken in is digested normally. Anemia is rare        and vitamin B12 deficiency is almost unknown. The patient does        have to be very careful to chew food completely to avoid        vomiting, and to avoid high calorie liquids such as regular        sodas and ice cream. A surgical variant of the VBG is the        Silastic Ring Vertical Gastroplasty (SRVG), which is        functionally identical to VBG but uses a silastic ring to        control the stoma size. These procedures were mostly abandoned        due to weight regain caused by gradual opening of the staple        line. Surgeons who previously performed VBG or SRVG migrated to        the more contemporary and successful RYGB and AGB (see below).    -   Roux-en-Y Gastric Bypass (RYGB) was also developed by Dr        Edward E. Mason, of the University of Iowa. It is mainly a        restrictive procedure, but also causes some malabsorption. Its        evolution since its introduction in 1967 is quite convoluted,        but it is an operation that has endured the test of time. With        one series of greater than 500 cases, followed for 14 years,        maintaining 50% excess weight loss, RYGB is the gold standard        for bariatric operations. The operation involves using a stapler        to close off most of the stomach leaving a small pouch at the        entrance. The small intestine is separated from the large one        and joined to the stomach pouch.

Besides causing significant weight loss, on the order of 70% excessweight loss (% EWL), RYGB brings about resolution of obesity relatedcomorbidities in most patients, including most cases of type 2 diabetes,obstructive sleep apnea, hypertension and hyperlipidemia (Buchwald,Avidor, Braunwald, et al. JAMA, October 2004). Additional studiesindicate a significant survival benefit for morbidly obese patient whoundergo RYGB as compared with morbidly obese controls who do not undergosurgery (Chritou N, et al. Ann Surg, August 2004).

Staple line failures with ensuing weight regain have been found to occurmany years after the procedure. As a result surgeons have responded byuse of techniques designed to prevent this including transection of thestomach, in which the staple line is divided and the cut ends oversewn.

The complications of gastric bypass are much less severe than those ofMalabsorptive procedures. Most large series studies report complicationsin two phases, those, which occur shortly after surgery, and those,which take a longer time to develop. The most serious acutecomplications include leaks at the junction of stomach and smallintestine. Complications which develop later include narrowing of thestoma (the junction between stomach pouch and intestine), which resultsfrom scar tissue development. This opening is made to be about 10 mm indiameter, therefore a very little scarring will reduce the opening to adegree that affects the patients eating. Wound hernias occur in 5-10%and intestinal obstruction in 2% of patients, an incidence similar tothat following any general surgical abdominal procedure. Metaboliccomplications that occur following RYGBP include anemia and calciumdeficit, because essential nutrients for blood production (iron andvitamin B12) depend on the stomach for absorption, and because calciumis best absorbed in the duodenum which is bypassed.

With the advent of laparoscopic surgery, a minimal access surgicalsolution for morbid obesity was investigated in many centers. Surgeonsin the US have developed laparoscopic techniques for performing a RYGB.These techniques are quite successful and currently over 75% of RYGBprocedures are done laparoscopically. Complication rate is low and earlyresults compare favorably with open RYBG. However, the technique ischallenging, and is associated with a long learning curve of about 100procedures.

Adjustable Gastric banding (AGB) represents a revival of horizontalgastroplasty in which a silicone band is placed around the stomach.There are two leading adjustable bands on the market today. One wasdeveloped jointly in Italy and in Belgium and the other in Sweden. Thedifferences between the two are small. In both, a silicone band, with aninflatable cushion inside is placed around the stomach, and sutured inplace. At a later date, the band is inflated to tighten the closure. Ifthe patient gains weight, the band is inflated again. If the patientloses too much weight, the band is deflated. The long-term results oflaparoscopic gastric banding are not known, but early results seem tocompare well with other purely restrictive procedures such as SRVG orVBG described above.

An endoscopic procedure for reducing capacity has been proposed in U.S.Pat. No. 6,572,629 by Kalloo, et al. In this method a ligating loop isclipped either to the interior of the stomach or around the outside ofthe stomach and pulled tight and tied in order to effectively reduce thesize of the stomach. The loop is attached to the interior walls of thestomach with a flexible endoscope introduced through the esophagus. Theloop is attached on the outside of the stomach by creating an opening inthe stomach and causing the end of the endoscope to exit the stomachinto the peritoneal cavity. Some of the techniques used are described inan earlier patent, U.S. Pat. No. 7,721,742, by the same inventors.

To summarize the current state of the art of surgical options in thetreatment of obesity, the ideal bariatric operation is one which issimple, carries few complications, and results in a predictable andsustained weight loss. Such an operation does not exist.

The best long-term results are 80% % EWL at 5 years, for the Biliarypancreatic bypass operation. However these results are achieved using avery complex operation, with a high complication rate in non-experthands. The various restrictive and hybrid operations yield a two-yearEWL of between 50% (AGB) and 65-70% (RYGB). These results are farsuperior to the results of non surgical treatment. Even the simplestgastric restrictive operation—stapled horizontal gastroplasty—issuperior to diet alone. Long-term success rate varies between 30 and 60%versus, 10-15% for the most successful nonoperative schemes.

However, because of the complications of surgery: any of the aboveprocedures is associated with some risk. For this reason the operativeapproach, using any of the known methods, is limited to the morbidlyobese. In these patients the risks are justified, even with theimperfect results of surgery. Patients who are merely obese, andcertainly overweight persons, are not candidates for any of theseprocedures. This mirrors the guidelines established by NIH in 1991 forweight loss surgery.

It is therefore a purpose of the present invention to provide bariatricprocedures that overcome the shortcomings of the prior art.

It is another purpose of the present invention to provide bariatricprocedures that are carried out endoscopically or laparoscopically.

It is a further purpose of the present invention to provide endoscopicand laparoscopic devices for carrying out bariatric procedures.

Further purposes and advantages of this invention will appear as thedescription proceeds.

SUMMARY OF THE INVENTION

The invention is a surgical method of treating morbid obesity. Themethod is carried out endoluminally or transluminally using endoscopicdevices that are introduced through natural body openings without thenecessity of creating any incisions in the abdominal wall.

A first aspect of the surgical method of the invention comprisespositioning an adjustable gastric band around a portion of the stomach.In one embodiment the adjustable gastric band is applied using atransgastric procedure. In another embodiment, carried out entirelywithin the stomach, the stomach wall is plicated and attached to theexternal wall of the cardia in at least two locations and the adjustablegastric band is applied within the stomach around the loops created bythe plications. In yet another embodiment the stomach wall is plicatedand attached to the external wall of the cardia in at least twolocations and the adjustable gastric band is applied around the outerwall of the cardia within the loops created by the plications.

A second aspect of the surgical method of the invention comprisesperforming the first stage of a gastric bypass procedure by bisectingthe stomach to form a closed pouch. The stomach can be bisected byintroducing the endoscopic devices transorally through the esophagusinto the stomach or through the anus and part of the colon into theabdominal cavity.

A third aspect of the surgical method of the invention comprises amethod of performing the second stage of performing a Gastric Bypassprocedure. The Gastric Bypass procedure can be a mini Gastric Bypass ora complete Roux-en-Y Gastric Bypass.

In a final aspect the invention is endoscopic devices that can beintroduced through natural body openings to carry out surgical methodsof treating morbid obesity endoluminally or transluminally.

All the above and other characteristics and advantages of the inventionwill be further understood through the following illustrative andnon-limitative description of preferred embodiments thereof, withreference to the appended drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B schematically illustrate a conventional endoscope;

FIG. 2 shows the handle of the prior art GERD endoscope;

FIG. 3A schematically illustrates the fixed portion and the articulationdistal portion of the prior art GERD endoscope, showing the componentsof the stapler assembly;

FIG. 3B schematically illustrates the articulation of the prior art GERDendoscope of FIG. 3A through its maximum bending angle;

FIG. 4 shows a preferred embodiment of the articulation section of theprior art GERD endoscope in its fully bent configuration;

FIG. 5 schematically shows the distal face of the prior art GERDendoscope;

FIG. 6 schematically shows the distal face of the prior art multipleworking channel endoscope;

FIG. 7 is a general view from above showing the side closing embodimentof the stapler of the invention located in the distal tip of anendoscope;

FIG. 8 shows the anvil removed from the endoscope;

FIG. 9 and FIG. 10 are views with parts of the surface removed to revealdetails of the interior of the distal tip;

FIG. 11 is a view with part of the wall of the staple cartridge removedto reveal its interior;

FIGS. 12A to 12F schematically show different stages in the operation ofthe side fastening embodiment of the endoscopic stapler used to close ahole in biological tissue;

FIG. 13 to FIG. 15 show the front fastening embodiment of the stapler ofthe invention in the open and closed configurations respectively;

FIGS. 16A to 16F schematically show different stages in the operation ofthe front fastening embodiment of the endoscopic stapler used to close ahole in biological tissue;

FIGS. 17A to 17D schematically illustrate a transgastric method ofapplying a gastric band that is very similar to the currently employedlaparoscopic method;

FIGS. 18A to 18G schematically show the steps of another method ofinserting a gastric band;

FIG. 19 schematically illustrates the last steps of another method ofinserting a gastric band;

FIGS. 20A to 20E schematically illustrate the steps of performing a miniGastric Bypass according to the invention;

FIGS. 21A to 21C illustrate a second way of endoscopically performing amini Gastric Bypass; and

FIGS. 22A to 22G schematically illustrate the steps of another method ofperforming a mini Gastric Bypass.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Many different types and embodiments of endoscopic apparatus have beendeveloped over a period of several years by the Applicant of the presentapplication. These inventions are described in published InternationalPatent Applications WO01/67964, WO/02/39909, WO02/24058, WO02/068988,WO2005/002210, WO2005/115221, WO2005/115255, WO2005/120329, andWO2006/033109 and in U.S. Pat. No. 7,530,984 all by the same applicanthereof, the descriptions of which, including publications referencedtherein, are incorporated herein by reference.

One or more of several different types of endoscopic devices are used tocarry out the novel transluminal procedures for treatment of morbidobesity to be described hereinbelow. All of these endoscopic devicescomprise at least one video camera and illumination fibers to providereal time visualization of the operating site. Cameras that have beendeveloped for use with endoscopes, including cameras having diameters ofless that can be installed on a distal tip of less than 2 mm diameterare described in WO2005/002210 and WO2005/115221. Cameras that are basedon CMOS and CCD technology can be manufactured at a cost that is lowenough to allow them to be discarded after a single use.

Each of the endoscopic devices is connected to an endoscopy suite suchas that described in WO2005/120329 to provide safe supply of light, air,vacuum, water, etc. as required for the particular phase of theprocedure for which the specific endoscope is employed.

The several basic types of endoscope that are required are: (a) a GERDtype endoscope with stapler; (b) a working channel endoscope, which hasno stapler but one or more working channels; (c) baby scope; (d) anendoscope with stapler on distal tip to close holes; (e) an endoscopewith one linear stapler on its distal end to simultaneously make twoparallel staple lines; and (f) an endoscope with two linear staplers onthe distal end to independently make two single staple lines.

A brief description of each of these types of endoscopic devicesfollows:

(a) GERD Type Endoscope with Stapler

WO01/67964 describes an endoscopic device comprising a surgical staplerattached to its shaft in such a way that bending the articulationsection of the endoscope through an angle of 270° brings the anvil ofthe stapler, located on the distal tip of the endoscope, into correctworking position with the cartridge containing the staples and staplefiring mechanism, located on the insertion section at the proximal endof the articulation section. The endoscope-stapler unit was initiallydesigned for performing fundoplication procedures as a treatment forGERD. Experienced persons will realize however, that the basic deviceitself and in particular the improvements to many of its components andsubsystems described in the other above referenced applications are notlimited to any particular application and can be either used asdescribed or modified mutatis mutandis by skilled persons for manyapplications in medicine and industry.

A conventional endoscope is illustrated in FIGS. 1A and 1B. Briefly theendoscope illustrated in FIG. 1A and generally indicated at 10, isprovided with a control section 12 (referred to as the “handle”,“control handle”, “operating handle”) provided with suction valves,operating switches, articulation lock, etc., switches 14-20 being markedfor illustrative purposes. Control wheels 22 are used for implementingthe bending of the articulation section, locking the articulationsection, activating accessories such as a stapler, etc. The endoscope 10also comprises a connector section 32, which is used to connect air andwater lines, light guides, etc. to the endoscope.

The light guide is indicated at 34, for illustration purposes. Theinsertion tube 24 consists of three separate sections: a flexibleportion 26, an articulation section 28 and a distal tip section 30.These latter three sections are shown in greater detail in FIG. 1B, inwhich is also shown the distal face 36.

The handle 12 of the endoscope includes connections, control knobs, andmechanisms for carrying out the functions of the endoscope. Thesefunctions include conventional operations, e.g. articulation, staplefiring, and specialized operations, e.g. staple cartridge indexing,advancement of the screws that lock the anvil to the cartridge,ultrasonic positioning that are unique to the endoscopes described inthe above referenced patent applications, which are suitable forcarrying out the procedure of the present invention. The handle isconnected by means of the universal multi-connector, vacuum and waterlines, etc. to an endoscopy suite such as that described inWO2005/120329.

In FIG. 2 is shown an illustrative handle 12 that comprises all of thecontrol elements needed to perform the method of the invention describedherein. In this figure are seen: the control knob 22 for bending of thearticulation section with associated lever 22′ which activates a ratchetmechanism for fine control of the bending and also locking thearticulation section; the staple firing lever 38 and associated lockinglever 38′, which prevents accidental firing of the staples; the entranceport 40′ to the working channel 40 (see FIG. 5); the proximal end of theinsertion tube 24; and the cable to the endoscopy suite 42. Not seen inFIG. 2 is the control lever for indexing the cartridge after each arrayof staples is fired, whish is located on the back side of the handleopposite the staple firing levers.

In FIG. 3A is shown the distal portion of the insertion tube of the GERDendoscope described in WO01/67964. The insertion tube in this endoscopecomprises a staple deployment system located in a recess 44′ in a rigidsection 26′ that is positioned between articulation section 28 andflexible section 26. The staple deployment system comprises a staplestorage facility (cartridge 44) and staple firing mechanism. The staplerdeployment system has a side firing design and requires an anvil whichis located on distal face 36 of the endoscope. The anvil is part of ananvil module 56 located in a recess in the distal tip 30. Both thestapler cartridge 44 and the anvil module 56 are preferably replaceable.

The staple and storage firing mechanism comprises staple cartridge 44containing one or more (three are shown) arrays of staples 46. Thestaples are fired by pulling firing cable 52 and the attached cams 50(located in the cartridge) proximally thus forcing staple pushers 48 tomove side wards and pushing the staples out of the cartridge 44. Numeral54 designates the indexing mechanism used to ready the next array ofstaples for firing by moving them into position opposite the anvil.

The articulation section 28 is similar in design to that of conventionalendoscopes, but possesses several unique features. Firstly, in order tosimplify the alignment procedure and at the same time achieve maximumaccuracy, a two-way articulation design is preferred, althoughendoscopes using four-way articulation sections are also available. Thisgenerally means that the articulating section is constrained to bend inone plane only. Secondly, the device is able to bend up to 270° in orderto carry out the required medical procedure, which is further than inconventional endoscopes. Finally, the articulating section is strongenough to provide a significant force against the tissues during fundusdistension, clamping, and stapling (as described in WO 01/67964, withreference to the illustrative surgical procedure).

FIG. 3B schematically shows the device of FIG. 3A in a fully articulatedposition. The articulation section 28 has been bent through bendingangle α using fixed radius of curvature “r”. The values of radius “r”and the length of the articulation section are determined by the fixedvalues “l” (length of the distal tip section 30) and “y” (the distancefrom the position at which the stapling is to be carried out to theinterface of the rigid section 26′ and the articulation section 28 ofthe endoscope) in such a way that articulation of the device completelybrings the two parts of the stapler assembly essentially into alignment.Final alignment is aided by various means (not shown in any of thefigures) such as an ultrasound system (best described in WO02/068988)and a special configuration of the matching faces of the anvil unit 56and cartridge 44 (best described in WO2005/115255). When the anvil hasbeen brought into correct working relationship opposite the cartridgescrews 58 that are stored in anvil unit 56 are advanced through thetissue pressed between the cartridge and anvil into matching bores inthe cartridge to provide exact alignment and distance and to clamp thetwo parts of the stapler together so that sufficient force can beapplied when firing the staples to insure that the legs of the staplesenter the recesses on the anvil and curl properly.

In FIG. 4 is shown the preferred embodiment (described in WO2006/033109)of the articulation section 28 of the GERD endoscope in its fully bentconfiguration. In the embodiment shown, articulation section 28comprises ten identical vertebrae 60 and two more vertebrae at each endthat are linked together end-to-end in a chain-like fashion. The two endvertebrae are nearly identical to the others except that the distal endof one and the proximal end of the other one are adapted to connect todistal tip 30 and rigid section 26′ of the insertion tube 24 of theendoscope respectively.

The articulation section of the GERD endoscope is designed to providetwo-way articulation through an angle of about 270 degrees. That is, asshown in FIG. 4, the articulation section can be bent in one directionin a plane that contains the longitudinal axis of the endoscope untilthe distal tip is brought to a position opposite the rigid section inthe shaft of the endoscope. When in this position the anvil unit 56 andthe cartridge 44 are said to be in correct working relationship.

FIG. 5 schematically shows a typical arrangement of the distal face 36of the GERD endoscope. Shown in the figure is an imaging channel is 62.Numeral 64 represents illumination fibers and numeral 66 designates anozzle for spraying water or air to clean the objective lens of thecamera. One imaging method that can be used is to place a miniatureelectronic camera unit (described in detail in WO2005/002210 andWO2005/115221) at the distal end of channel 62. Placement of imagingmeans at the distal tip assists in guiding the device to the desiredposition in the body lumen and allows imaging of the area during theperformance of the surgical procedure. The endoscope may contain two ormore separate optical channels that produce two or more distinct views,e.g. a second optical imager can be provided to view through a clearportion of the stapler and will show the staples as they are passedthrough the tissue and bent closed. Various embodiments of suitableendoscopic optical systems are described in WO02/24058.

Numeral 68 designates the anvil unit face; numeral 58 designates thealignment/locking screws, which are contained in the anvil unit; andnumeral 70 designates the depressions for curling the legs of thestaples when they are ejected from the cartridge. Numeral 72 designatesan ultrasound transducer or reflector that is part of the alignmentsystem. A working channel for introducing surgical tools, suction, orirrigation is shown at 40. The skilled person will understand that otheroptions can be provided and other configurations are allowed dependingon the requirements of the endoscopic procedure to be performed. Forexample, more than one working channel 40 can be provided.

The GERD endoscope is a very robust endoscope that has been designed formultiple uses and to perform medical procedures that require theapplication of considerable force, e.g. when firing the staples. Typicaldiameters of a GERD endoscope are 11-16.5 mm.

(b) Working Channel Endoscopes:

The endoscopic device called a “working channel endoscope” herein hasthe same basic structure as the GERD endoscope with the exception thatthere is no stapler unit and therefore no mechanism for staple firingand indexing. Also typically the ultrasound positioning system is notneeded, although for some procedures ultrasound imaging may be used. Themain feature of these endoscopes is that they have at least one andtypically two to five working channels. This feature, in combinationwith excellent visualization provided by the camera on the distal faceand the controlled flexibility of the articulation section, makes theseendoscopes versatile tools for carrying out complex procedures thatrequire the simultaneous use of several surgical tools. The overalldiameter of the endoscope and the number and diameters of the workingchannels depends on the requirements of the procedure. FIG. 6schematically shows the distal face of a multiple working channelendoscope. In this example are shown the camera 62, illumination fibers64, spray nozzle 66, and four working channels 40 having differentdiameters. Typical diameters of the multiple working channel endoscopeare 2.8 mm with an internal 1.2 mm working channel and up to 16.5 mmwith several working channels having different diameters. The workingchannel endoscope can be sterilizable and used for many procedures ormade for a single use only, with a disposal camera or only the camerahead being reusable.

c) Baby Scopes

Embodiments of endoscopes having diameters of less than 3 mm to 5 mmcomprising distal tip cameras and articulation sections of the samedesign and capabilities as those of the larger diameter endoscopes thathave been developed are known as babyscopes. The baby scopes are usuallymade to be disposable after a single use.

The baby scopes developed by the applicant of the present invention aredistinguished from currently available small diameter endoscopes by theuse of the video camera. The prior art scopes of this type depend on theuse of fragile fiber optics to transfer the image gathered by anobjective lens from the distal tip to proximal imaging means. Because ofthe breaking of the optical fibers, the endoscopes generally have a veryshort useful lifetime despite the fact that they are sterilizable, meantto be used for many procedures, and very expensive.

(d) Endoscope with Distal Tip Stapler to Close Holes

This endoscope is designed exclusively for closing holes in biologicaltissue. The endoscope itself, with the exception of the distal tip isessentially the working channel endoscope described above, with theaddition of a cable to move the anvil longitudinally, thereby firing thestaples as described hereinbelow. The distal tip is modified toaccommodate two basic embodiments of a surgical stapler—the firstclosing at right angles to the longitudinal axis of the endoscope andthe second in the direction of this axis.

FIG. 7 is a general view from above showing the side closing embodimentof the stapler located in the distal tip 30 of an endoscope. On thedistal face 36 can be seen a camera 62; the ends of two illuminationfibers 64, which provide light to illuminate the field of view of thecamera; two nozzles 66 to spray air or water to keep the camera lensclean; and a working channel 40, which can be used to introduce otherdevices, e.g. ultrasound probe, forceps, needles, etc. Experiencedpersons will recognize that the configuration and type of elements shownon the distal face in the figures is illustrative only, is not crucialto the present invention, and is related to the particular procedure tobe performed and to the accessories provided.

The stapler is comprised of two components: the anvil 74, which is asemicircular flat surface at the bottom of which are attached two legs76, a staple cartridge 78, which contains an array of staples that exitthrough slots 80 when the stapler is activated as described hereinbelow.The stapler cartridge is composed of two sections: a proximal section 78₁, which is either fixedly attached to or manufactured as an integralpart of the distal tip, and a distal section 78 ₂, which can be slidinto proximal section 78 ₂ by pushing on the distal face of section 78₂. In the side closing embodiment of the stapler the cartridge 78 andanvil 74 are located at the proximal and distal ends respectively of arecess cut into the side of distal tip 30. On the floor of the recessare located a camera 62, one or more illumination fibers 64, and wateror air nozzles 66 in order to visualize the hole and the tissue graspingprocedure as well as to inspect the tissue after the staples are ejectedfrom the cartridge. It is to be noted that here, as in the otherendoscopic devices described herein, the illumination for visualizationcan be provided by alternate means well known to skilled persons, e.g.LEDs. All references in the description herein to illumination fibers ismeant to refer to alternate illumination means as well. In order tograsp the tissue, there are provided two screws 82 comprised of stiffwire bent into a spiral shape. The screws 82 pass through overtubes 84located in channels through the insertion tube of the endoscope. Theycan be independently advanced, withdrawn, and rotated about theirlongitudinal axis from the handle at the proximal end of the endoscope.

It is to be noted that here, as in the case of the other endoscopicdevices described herein, the illumination for visualization can beprovided by alternate means well known to skilled persons, e.g. LEDs.All references in the description herein to illumination fibers are tobe understood to refer to alternate illumination means as well.

FIG. 8 shows the anvil 74 removed from the endoscope. In the figure thedepressions 70 into which the legs of the staples enter and are curledwhen the staples are ejected from the stapler are seen on the face ofthe anvil. The stapler can be designed to utilize different sizes ofstaples depending on the diameter of the endoscope and properties of thetissue to be fastened. Typical standard sizes that can be used are 2,2.5, 3, 3.3, and 4.8 mm metal staples. Biodegradable staples can also beused.

In FIGS. 7 to 10, the diameter of the endoscope is 12-15 mm and thestapler comprises an array of four 4.8 mm staples.

FIG. 9 and FIG. 10 are views with parts of the surface removed to revealdetails of the interior of the distal tip 30. In FIG. 9 can be seen thechannel 86, through which the overtube 84 and screw 82 are advancedthrough the length of the endoscope. In FIG. 10 can be seen the slots 88in which the legs 76 of the anvil can slide. Not shown in FIG. 10 is acable that is attached to the proximal end of each leg 76, passesthrough the center of spring 90, and then passes through a channel inthe insertion tube of the endoscope to the handle where its proximal endis attached to a mechanism that can be used to pull the entire anvil 74in a proximal direction. When anvil 74 is pulled in a proximaldirection, the proximal end of spring 90 butts up against a stopper (notshown) and is compressed. When the tension on the cable used to pull theanvil proximally is released, spring 90 pushes anvil 86 in the distaldirection.

FIG. 11 is a top view with part of the wall of the staple cartridge 78removed to reveal its interior. The cartridge 78 of the stapler of theinvention does not comprise any arrangement of cams to actively fire thestaples. When the anvil 74 is pulled proximally as described hereinabove, the face of anvil 74 engages the face of cartridge 78 and pushesdistal section 78 ₂ proximally causing it to slide into proximal section78 ₁. Neither the staple pushers 48 nor the staples 46 move. The staplepushers merely act as a backstop to prevent staples 46 from moving inthe proximal direction. In this way the legs of staples 46 are passivelyforced to exit the distal part 78, of the cartridge through slots 80 andengage the matching depressions 70 on the face of anvil 74. Continuedpulling on the cables attached to the legs 76 of the anvil 74 cause moreand more of the length of the legs of staples 46 to exit through slots80 and the legs of the staples start to curl. The process continuesuntil the staples 46 completely exit the cartridge 78 and the staplingprocess is completed. The cartridge 78 may contain one or more springsto provide a gradually yielding counter force to that exerted by theanvil, thereby aiding to provide a smooth exit of the staples and, ifnecessary, to return distal section 78 ₂ to its original position as theanvil moves in the distal direction.

FIGS. 12A to 12F schematically show different stages in the operation ofthe side fastening embodiment of the stapler to close a hole inbiological tissue. The procedure is as follows:

FIG. 12A—The endoscope is inserted into the body cavity using the camera62 on the distal face 36 for visualization until the hole in the tissueis viewed using the side facing camera 62.

FIG. 12B—The overtubes 84 are pushed out of the channels 86 and thescrews 82 are advanced and rotated until they penetrate and grab thetissue on opposite sides of the hole.

FIG. 12C—The overtubes 84 and the screws 82 with the tissue attached arepulled back into channels 86.

FIG. 12D—The cables attached to the legs 76 of the anvil 74 are pulledcausing anvil 74 to move towards cartridge 78.

FIG. 12E—The tissue is compressed between the faces of the anvil 74 andthe cartridge 78 and moveable cartridge section 78, begins to slide intofixed cartridge section 78 ₁. The legs of staples 46 begin to exit theslots 80, penetrate the layers of tissue and curl in the depressions 70.

FIG. 12F—The stapling has been completed, screws 82 have been rotated torelease their grip on the tissue, the cables attached to legs 76 havebeen released, and springs 90 have pushed the anvil 74 back to itsoriginal position, thereby freeing the stapled tissue. The closed holeis now inspected using the side viewing camera 62 and the endoscope canbe withdrawn. If the hole is a large one, another endoscope containing astapler of the invention can be introduced to the site of the hole andthe same procedure followed again to apply a second array of staplesnext to the first array.

FIG. 13 to FIG. 15 show the front fastening embodiment of the stapler ofthe invention. Most of the components of the stapler according to thisembodiment and its operation are the same as for the side fasteningembodiment mutatis mutandis and will not be further described. The majordifference between the two embodiments being that in the front fasteningembodiment a mechanism activated from the operating handle of theendoscope, e.g. a spring loaded cam system, must be provided to raiseand lower the anvil to enable the tissue to be grabbed and pulledbetween the faces of the anvil and the cartridge for stapling.

FIGS. 16A to 16F schematically show different stages in the operation ofthe front fastening embodiment of the stapler to close a hole inbiological tissue. The procedure is as follows:

FIG. 16A—With the anvil lowered, the endoscope is inserted into the bodycavity using the camera 62 on the distal face 36 for visualization. Theendoscope is advanced and steered until the hole in the tissue is vieweddirectly in front of the camera.

FIG. 16B—the mechanism is activated from the control handle of theendoscope causing the anvil to be pushed out of the distal end;

FIG. 16C—as the anvil continues to advance out of the end of theendoscope, it gradually opens;

FIG. 16D—The overtubes 84 are pushed out of the channels 86 and thescrews 82 are advanced and rotated until they penetrate and grab thetissue on opposite sides of the hole.

FIG. 16E—The overtubes 84 and the screws 82 with the tissue attached arepulled back into channels 86, the anvil is pulled distally towards theface of the cartridge forcing the anvil down into its lowered position,the tissue is compressed between the faces of the anvil 74 and the faceof cartridge 78, moveable cartridge section 78 ₂ begins to slide intofixed cartridge section 78 ₁, the legs of staples 46 begin to exit theslots 80 penetrate the layers of tissue and curl in the depressions 70.

FIG. 16F—The stapling has been completed, screws 82 have been rotated torelease their grip on the tissue, the anvil 74 is returned to its openposition, thereby freeing the stapled tissue. The closed hole is nowinspected using the camera 62 and the endoscope can be withdrawn. If thehole is a large one, another endoscope containing a stapler of theinvention can be introduced to the site of the hole and the sameprocedure followed again to apply a second array of staples next to thefirst array.

(e) Endoscope with Linear Stapler on Distal End

In some of the procedures described below it is necessary to insert adouble line of staples and to cut the tissue between the staple lines,e.g. to bisect the stomach. This is done using an ordinary endoscopiclinear stapler. The stapler can be introduced through a working channelin a working channel endoscope. Alternately the stapler can bepermanently fixed to the distal end of an endoscope to form a dedicatedendoscopic device that also comprises an articulation section and cameraon the distal tip. The linear stapler may hold only one array ofstaples, but preferably it has two or more arrays and it can be indexedto bring the next array into position for firing. Alternately thestapler may comprise a magazine of staples, which are automaticallyloaded into the array after the previous staples are fired. The arraysof staples are arranged to insert two parallel rows of staples into thetissue held between the two jaws of the stapler. Preferably the stapleralso has a knife blade, which can be moved in a slot between the tworows of staples to cut the tissue after the staples have been fired.

(f) Endoscope with Two Linear Staplers on the Distal End

The linear stapler described above is used to simultaneously produce twoparallel staple lines. An endoscopic device of the type shownschematically in FIG. 22B is used to produce the staple linesindependently. In this case two linear staplers, each of which fires anarray comprising one row of staples, is attached to the distal end ofthe endoscope. The staplers can be introduced through working channels,but are preferably permanently affixed to a dedicated device. Thestaplers can comprise one or more arrays of staples and at least one ofthe staplers comprises a knife blade for cutting the tissue parallel tothe staples.

The endoscopic instruments described hereinabove can be used to performendoluminally several types of operations for treatment of morbidobesity that are today carried out either laparascopically or using opensurgery. As examples only, embodiments of the invention for insertinggastric bands and performing a mini and a complete Roux-en-Y GastricBypass will be presented.

Gastric Banding Embodiment I

This is a transgastric method of applying a gastric band that creates avery similar anatomic outcome to the currently employed laparoscopicmethod but is carried out by introducing the band and all the surgicaltools endoluminally. In this way the necessity of creating the minimumof five entry ports in the abdominal wall that are required in thelaparoscopic method is eliminated. In addition, the procedure may bedone under conscious sedation as gastroscopy is done, thus obviating theneed for general anesthesia which is the norm in laparoscopic surgery.The procedure is schematically illustrated in FIGS. 17A to 17D.

The endoscopic device that is suitable for carrying out this operationis an embodiment of the working channel endoscopes described above. Allphases of the procedure are executed using visualization provided by thevideo camera on the distal tip of the endoscope. The adjustable band 100is grasped in front of the distal tip 30 of the endoscope 10 by aforceps 104 that passes through one of the working channels. Theadjustable band 100 and endoscope 10 are introduced transorally throughthe esophagus 210 and the lower esophageal sphincter (LES) 212 into thestomach 200 of the patient. Once in the stomach 200 the articulationsection 28 is bent to bring the distal tip close to the upper part ofthe greater curve 204 of the stomach. At this location a hole is made inthe stomach wall by means of a surgical cutting tool that has beenintroduced to the operating site through a second working channel. Thedistal end of endoscope 10 and attached band 100 are pushed through thehole (FIG. 17B) and the articulation section 28 bent to bring the distaltip 30 near the fundus 202. Various grasper and separator tools are usedto slide the band 100 around the upper part of stomach 200. The band 100is placed at a diagonal from a location on the fundus 202 slightly abovethe top of the greater curve 204 to a point on the upper part of thelesser curve 206. Grasping and other tools introduced through theworking channels are used to manipulate perigastric tissues, e.g. thefat pad, move the band 100 into position, pull the band tight, andattach its two ends together (FIG. 1C). A baby scope may be introducedthrough a working channel of the endoscope and used to manipulate theband around the posterior side of the stomach under visualization by thedistal tip camera of the baby scope. After band 100 is fastened it isreleased, the articulation section is straightened and repositioned, andthe free end of the inflation tube 102 of the band 100 is grasped by agrasping tool and is maneuvered into position and attached to aconnection on a port that has been implanted in the abdominal wall ofthe patient. Finally, the endoscope 10 is withdrawn from the patient. Asecond endoscope with a front closing stapler mounted on its distal tipis now inserted into the stomach and used to close the hole around thetube 102, after which the stapler is also withdrawn. The result of theprocedure is shown in FIG. 17D. Band 100 is wrapped tightly around thestomach forming a small pouch 214 below LES 212. Food can flow frompouch 214 into the lower part of the stomach by passing through a stomacreated by the band 100. The diameter of the stoma can be adjusted byinserting or withdrawing a fluid such as air or saline solution from aballoon-like compartment on the inside surface of band 100 via theimplanted port and tubing 102.

Gastric Banding Embodiment 2

A second embodiment of the invention is based on the use of the GERDendoscope and the method of using it to perform a fundoplication that isdescribed in WO 01/067964. The steps of the method of inserting thegastric band are schematically shown in FIGS. 18A to 18G. The GERDendoscope 10 is first introduced through the esophagus 210 into thestomach 200 and bent so that the distal tip 30 engages the wall of thestomach 200 about at the location where the upper part of the greatercurve 204 joins the fundus 202 (FIG. 18A). The articulation section 28is bent further until the outer side of the stomach wall is folded backand pressed against the outer side of the cardia 213 (FIG. 18B). Anarray of staples 106 is fired to attach the walls to each other creatinga full loop 216 ₁. The endoscope 10 (now shown in the FIG.) is thenstraightened, rotated about 180 degrees and bent and advanced until itcontacts the stomach wall along the lesser curvature (FIG. 18C). Asbefore on the other side of the stomach, the stomach wall is raised andthe outer wall of the lesser curve is stapled to the wall of the cardia213 creating full loop 216 ₂ (FIG. 18D). This procedure can be repeatedto create more than two similar loops if required. The GERD endoscope isnow withdrawn from the patient and a working channel endoscope with anadjustable band 100 held in front of it by a grasping tool 104 isintroduced through the esophagus into the stomach (FIG. 18E). Thearticulation section of the endoscope is bent to bring the distal tipand the band close to the upper part of the stomach (FIG. 18F). Usinggrasping tools the band is wrapped around the outside of loops 216 ₁ and216 ₂ and the ends of the band are joined. Sutures or staples may be putaround the band or gastro-gastric sutures applied, as is commonly done,in order to prevent migration or slippage.

The distal tip of the endoscope is now positioned at the wall of thestomach. A cutting tool is introduced through one of the workingchannels and a hole made in the stomach wall. The endoscope is pushedthrough the hole and the free end of the inflation tube 102 of the band100 is grasped by a grasping tool and is maneuvered into position andattached to a connection on a port that has been implanted in theabdominal wall of the patient. The steps of positioning and connectinginflation tube 102 may be more conveniently carried out by means of ababy scope. The endoscope is withdrawn from the patient and a thirdendoscope with a front closing stapler mounted on its distal tip is nowinserted into the stomach and used to close the hole around the tube102, after which the stapler is also withdrawn. The result of theprocedure is shown in FIG. 18G.

Gastric Banding Embodiment 3

Most of the steps of the third embodiment are essentially the same asthose of the second embodiment. The steps shown in FIG. 18A to FIG. 18Fare identical. FIG. 19 is used to illustrate the final steps of theprocedure. Referring now to FIG. 18F, when the articulation section ofthe endoscope is bent to bring the distal tip and the band close to thewall of the cardia, a cutting tool is passed through a working channeland is used to make a small hole in the lower part of the wall of thecardia 213. Grasping tools passed through the working channel of theendoscope are now used to pull the band out of the stomach through thehole and to wrap it around the outside of the cardia and join the endsof the band together. After the ends of the band are joined, the distaltip of the endoscope is now positioned at the wall of the stomach. Acutting tool is introduced through one of the working channels and ahole made in the stomach wall. The endoscope is pushed through the holeand the free end of the inflation tube 102 of the band 100 is grasped bya grasping tool and is maneuvered into position and attached to aconnection on a port that has been implanted in the abdominal wall ofthe patient (FIG. 19). In this embodiment, the band is held in placearound the outer wall of the cardia by the plicated and stapled walls ofthe stomach. It should be noted that this embodiment can be carried outby stapling the wall of the stomach to the cardia at more than twolocations. In addition, it is easier to make the hole and attach theband after the stomach wall is attached on one side only (e.g. as shownin FIG. 18C). If this is done it will be much easier to attach andfasten the band. Also if the second side is stapled after the band isalready in place, it can be attached to the cardia such that the band ismore tightly held then in the method described above.

Mini Gastric Bypass or Roux-En-Y Gastric Bypass Embodiment 1

FIGS. 20A to 20E schematically illustrate the steps in performing a miniGastric Bypass. An endoscope 10 having at least one working channel anda linear stapler 108 that applies two parallel lines of staples andvideo camera on its distal face is inserted into the stomach 200 throughesophagus 210. A cutting tool introduced through the working channel isused to cut a hole in the wall of the upper part of stomach 200. Theendoscope is then pushed transgastrically and articulated so that thejaws of the stapler face the exterior of the stomach (FIG. 20A). Thejaws of the stapler are then closed grabbing the tissue and an array ofstaples are fired to make a double line of staples 110 below the hole inthe stomach wall. A surgical knife (not shown) in the stapler isactivated to cut the tissue between the lines of staples. The jaws ofthe stapler are then opened, the endoscope is moved forward until moreof the stomach is between the walls, the jaws are closed, a second arrayis fired to lengthen staple lines 110 and the tissue is again cut (FIG.20B). This procedure is repeated as many times as necessary until thestomach has been bisected into two parts, an upper small pouch 214 and alower part 200′ (FIG. 20C). The endoscope is now maneuvered until it isin a position that a grasping tool can be used to grab the intestine 218(FIG. 20D). In order to create a mini gastric bypass, the endoscope isnow pulled in the proximal direction until the grabbed part of theintestine is pulled into the hole in pouch 214. A hole is now made inthe wall of intestine 218 and it is connected to pouch 214 byconventional means, e.g. an anastomosis button 112, staples, or clips(FIG. 20E). The procedure has been described as if carried out using asingle endoscope, however it is clear that more than one dedicatedendoscope can be used to perform different steps in the procedure.

Once the gastric pouch has been created using the minimal invasivemethod of the invention (FIG. 20C), the physician may choose to create amini gastric bypass as described in the last paragraph, or alternativelyutilize any minimally invasive approach that he wishes to cut andconnect a small intestine Roux limb in order to complete a Roux-en-Yprocedure. It is important to note that sometimes the liver may coverpart of the stomach, hence obstructing the path for stapling and cuttingthe stomach. This obstacle is overcome by using one of the workingchannels of the endoscope to place a balloon having a cylindrical orsimilar shape with a hole in its middle between the liver and externalstomach wall. Inflating the balloon will separates the two organs andcreates a clear path for the endoscope and the stapler. Near the end ofthe procedure the balloon is deflated and withdrawn with the endoscopethrough the incision into the stomach and out of the patient's body.

Mini Gastric Bypass or Roux-En-Y Gastric Bypass Embodiment 2

FIGS. 21A to 21C illustrate a second way of endoscopically performing amini Roux-en-Y Gastric Bypass. Instead of starting the procedure byintroducing the endoscope transorally, an endoscope is introducedthrough the anus into the colon. A hole is made in the wall of colon 220and an endoscopic device 10 comprising linear stapler 108 is pushed outthrough the hole and advanced until it is facing the stomach (FIG. 21A).The stomach is bisected as described with respect to embodiment 1 (FIG.21B). After the stomach is completely bisected to separate pouch 214from the remainder of the stomach 200′, the endoscope with the linearstapler is withdrawn (FIG. 21C). The procedure is completed byintroducing a working channel endoscope through the hole in the colon tobring a loop of intestine 218 (transected as a Roux limb or nottransected as in a mini gastric bypass) to the pouch. In this transcolon approach the operating tools are already in the abdominal cavity,therefore the entire procedure can be completed without entering theesophagus and making a hole in the stomach. After connecting the loop tothe bowel an endoscope with stapler on the distal end is introduced tothe colon and used to seal the hole.

Roux-En-Y Gastric Bypass Embodiment 3

FIGS. 22A to 22G schematically illustrate the steps of another method ofperforming a mini Roux-en-Y Gastric Bypass. In embodiment 1, describedhereinabove, the articulation section of the endoscope must be bentthrough approximately 180 degrees in the abdominal cavity in order tobring the stapler into the correct orientation to begin bisection of thestomach. The present embodiment eliminates the necessity of transgastricarticulation of the endoscope.

The endoscope is introduced through esophagus 210 into stomach 200. Ahole is made in the stomach wall with a surgical cutting tool introducedthrough a working channel. After the hole has been made, the distal endof endoscope 10, which has two linear staplers 114 a and 114 b attachedto it, is pushed through the hole to the outside of the stomach (FIG.22A). The jaws of the staplers, which were held in the closedconfiguration while the endoscope was moved to the operating site, arethen spread apart (FIG. 22B). The endoscope is then pulled in theproximal direction, the tissue of the stomach on either side of the holeslides between the open jaws of the staplers, the jaws are closed, andthe staples are fired. Each of the staplers 114 a and 114 b fires anarray that produces a single staple line 110. It should be noted thatembodiments of linear staplers that apply a double or triple staple linemay also be utilized if the surgeon prefers such an approach, as somesurgeons currently do in some laparoscopic or open gastric bypass cases.Finally a knife attached to one of the staples is used to slice thetissue between the staple lines (FIG. 22C). The jaws of the staplers arethen opened, the endoscope moved proximally and another “bite” is takenincreasing the length of staple lines 110. When it is time to performthe last “bite”, which will bisect the stomach, stapler 144 a is notactivated (FIG. 22D). The result is that the stomach is bisected intotwo parts, the larger lower part 200′, whose upper edges are entirelyclosed by staple line 110 and an upper pouch 214, which has a hole 116in it (FIG. 22E).

After completing the bisection of the stomach the stapler endoscope iswithdrawn and a working channel endoscope introduced. The workingchannel is pushed through hole 116 in pouch 214 and maneuvered until theintestine 218 can be grabbed (21F). Finally the endoscope and grabbedintestine are pulled back to the hole where the intestine 218 isattached to pouch 214 by conventional means, e.g. anastomosis button 112to complete a mini gastric bypass procedure (FIG. 22G). As in theprevious embodiments, starting from the stage shown in FIG. 22 e, thesurgeon can choose any minimally invasive approach that he wishes to cutthe small intestine and connect a Roux limb in order to complete aRoux-en-Y procedure.

Although embodiments of the invention have been described by way ofillustration, it will be understood that the invention may be carriedout with many variations, modifications, and adaptations, withoutexceeding the scope of the claims.

The invention claimed is:
 1. A surgical method comprising positioning anadjustable gastric band having two ends that can be joined around aportion of a stomach, wherein said surgical method is carried out usingendoscopic devices introduced through natural body openings withoutcreating any incisions in the abdominal wall for the introduction ofsaid endoscopic devices, wherein the adjustable gastric band is appliedaround the portion of the stomach using a transgastric procedure carriedout by introducing the adjustable gastric band and all surgical toolsendoluminally, wherein said surgical method comprises steps ofintroducing the gastric band and an endoscopic device into the stomachwithout creating an incision in the abdominal wall, using saidendoscopic device to cut a hole in a wall of said stomach, withdrawingsaid endoscopic device from said stomach, and introducing into saidstomach a second endoscopic device having a stapler mounted on a tip ofsaid second endoscopic device, and using said stapler to close saidhole.
 2. A surgical method for performing a first stage of a GastricBypass procedure said surgical method comprising: bisecting a stomach toform a closed pouch, said surgical method carried out using endoscopicdevices introduced through natural body openings without creating anyincisions in the abdominal wall for the introduction of said endoscopicdevices, wherein, one of said endoscopic devices comprises at least oneworking channel and a distal end, said one of said endoscopic devicesalso comprises on said distal end at least one linear stapler thatapplies two parallel lines of staples and a video camera, said videocamera adapted and oriented to provide a visual representation of ananatomical structure and any surgical or diagnostic tools present in afield of view of said video camera.
 3. A surgical method according toclaim 2, wherein the endoscopic devices are introduced transorallythrough the esophagus into the stomach.
 4. A surgical method accordingto claim 2, wherein the endoscopic devices are introduced through theanus and part of the colon into the abdominal cavity.
 5. A surgicalmethod according to claim 2 further comprising the step of performing asecond stage of the Gastric Bypass procedure.
 6. A surgical methodaccording to claim 5, wherein the Gastric Bypass procedure is a miniGastric Bypass.
 7. A surgical method according to claim 5, wherein theGastric Bypass procedure is a complete Roux-en-Y Gastric Bypass.
 8. Asurgical method comprising positioning an adjustable gastric band havingtwo ends that can be joined around a portion of a stomach, wherein saidsurgical method is carried out using endoscopic devices introducedthrough natural body openings without creating any incisions in theabdominal wall for the introduction of said endoscopic devices, whereinthe stomach wall is plicated, forming plications, and attached to anexternal wall of a cardia in at least two spaced apart locations using aGERD endoscope, wherein a working channel endoscope with the adjustablegastric band held in front of the working channel endoscope by agrasping tool is introduced through the esophagus into the stomach,wherein the adjustable gastric band is implanted using the graspingtool.
 9. A surgical method according to claim 8, wherein the adjustablegastric band is applied within said stomach around loops created by saidplications.
 10. A surgical method according to claim 8, wherein theadjustable gastric band is applied around said external wall of thecardia within loops created by said plications.